BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILE

    MDR report key: 8019997 · Received October 30, 2018

    Report

    Report Number
    1836161-2018-00109
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 1, 2018
    Report Date
    October 2, 2018
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    FTA
    PMA / PMN Number
    K020304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT A FLEXIBLE LIGHT HANDLE COVER WAS DISCOVERED WITH A POTENTIAL SEAL ISSUE. SAMPLES WERE NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE LOT NUMBERS. NO NON-CONFORMANCE'S WERE NOTED RELATING TO THE REPORTED ISSUE. POUCH MATERIAL OF THE PRODUCT IS A BREATHABLE PACKAGING MATERIAL AND WOULD ALLOW AIR TO ESCAPE FROM INSIDE THE POUCH. DUE TO NO SAMPLES PROVIDED, NO FURTHER INFORMATION IS AVAILABLE ON THE PRODUCT AT THIS TIME. NO FURTHER ACTIONS REQUIRED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT A FLEXIBLE LIGHT HANDLE COVER WAS DISCOVERED WITH A POTENTIAL SEAL ISSUE. THE ITEM WAS NOT IN USE. NO INJURY/DEATH WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM FOR MULTIPLE LOTS AS FOLLOWS: (B)(4) - LOT 142114. (B)(4) - LOT 130570.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861289 ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILE LIGHT HANDLE FTA ASPEN SURGICAL PRODUCTS, CALEDONIA LT-F01B SEE ABOVE

    Patients

    Seq Age Sex Outcome Treatment
    1